FPs, Patients Score Big Win as FDA Finalizes Tobacco Rule

E-cigarettes, Cigars, Hookah and Pipe Tobacco All Fall Under Agency's Sway

May 06, 2016 04:31 pm News Staff
[No sale to minors with picture of e-cigarette on red background]

Talk about a big victory for the AAFP, its members and their patients.

"It has been five years since the Food and Drug Administration first indicated it would take action to regulate all tobacco products and almost two years since the Food and Drug Administration (FDA) formally proposed a regulation to extend its authority over all currently unregulated tobacco products, including e-cigarettes and cigars."

So begins an April 13 letter(5 page PDF) to President Obama from the AAFP and other health care groups calling for his leadership to ensure swift action to finalize the agency's proposed tobacco deeming rule.

On May 5 -- three weeks to the day since that letter was sent -- the FDA did just that.

Better still, the 499-page final rule(www.federalregister.gov) includes key points the Academy has long demanded.

Story Highlights
  • The AAFP welcomed the May 5 release of the FDA's final tobacco deeming rule.
  • The rule incorporates key actions the Academy has advocated for many years, including deeming e-cigarettes and other nicotine-delivery devices to be tobacco products and, therefore, subject to the FDA's regulatory authority.
  • The rule also imposes significant restrictions on these products, such as prohibiting their sale to minors.

"Family physicians across the country applaud the FDA's final regulation of e-cigarettes, cigars, pipe and hookah tobacco, and other related products," said AAFP President Wanda Filer, M.D., M.B.A., of York, Pa., in a statement. "Tobacco use is the leading preventable cause of death and illness in the U.S., and by including e-cigarettes and other nicotine-delivery devices not previously under the FDA's authority, the agency asserts its commitment to protecting public health."

Filer also celebrated the action in a video released via social media within hours of the news. (Watch the video below.)

Breaking It Down

First, a little background: Cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco were immediately covered by the tobacco product authorities in the Food, Drug and Cosmetic Act (FD&C Act) when the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was enacted in 2009. For other types of tobacco products, the Tobacco Control Act authorized the agency to issue regulations "deeming" them to be subject to those same tobacco product authorities.

"This rule gives the 2009 Family Smoking Prevention and Tobacco Control Act the full authority it's lacked since becoming law," Filer noted. "Now, those products that have been in the marketplace since 2007 will be regulated.

"By retroactively regulating these products, the FDA prevented a very dangerous and concerning precedent, which would have allowed these harmful products to go unchecked and continue to be sold."

The purpose of the new FDA rule is twofold:

  1. to deem additional products that meet the definition of "tobacco product," including essential components or parts of those products, and subject them to the tobacco product authorities in the FD&C Act and the agency's implementation regulations; and
  2. to establish specific restrictions for those newly deemed products that the agency considers necessary to protect public health.

Key among those restrictions is the agency's decision to prohibit the sale of all such products to individuals younger than 18, as well as a requirement that appropriate health warnings be displayed on "cigarette tobacco, roll-your-own tobacco, and covered tobacco product packages and in advertisements."

"The FDA asserted its commitment to keeping tobacco out of the hands of minors by setting the legal age to purchase e-cigarettes to 18 and requiring picture identification" to purchase the products, said Filer. "Moreover, eliminating free samples and restricting the sale of tobacco products to only adult-accessible vending machines will help keep tobacco products out of the hands of children."

Reviewing the AAFP's Efforts

Safeguarding patients' health, regardless of age, has spurred the Academy's longstanding and wide-ranging advocacy on tobacco prevention and control. It's a mission the AAFP has embraced for decades, as evidenced by its involvement in the Tar Wars tobacco-free education program for fourth- and fifth- graders and development of the Ask and Act tobacco cessation program, among other projects and resources.

In addition to the AAFP's direct outreach to the FDA(2 page PDF) pressing the agency to assert its regulatory authority over tobacco and nicotine-delivery products, the Academy also has vigorously pursued the topic in Congress.

For example, shortly after the proposed rule was released, the AAFP joined other groups in writing to leaders of the House Committee on Appropriations, them not to "impede the current rulemaking process the FDA has initiated to determine the appropriate level of oversight for tobacco products not currently regulated by the agency." In that instance, the committee was considering a potential amendment to the FDA funding bill that would exempt cigars from the deeming rule.

In March 2015, the AAFP signed on to a joint letter to House members strongly urging them to oppose a bill that would have exempted "traditional large and premium cigars" from regulation under the Tobacco Control Act.

And in December of that year, the Academy and 51 of its constituent chapters wrote House leaders to protest another bill that "would entirely undermine the FDA's ability to review tobacco products, such as cigars and e-cigarettes."

The flip side of these actions has been the AAFP's support for other legislation(1 page PDF) that would strengthen oversight of such products.

Related AAFP News Coverage
AAFP Joins Push for Obama to Expand FDA Tobacco Regulation

Include Cigars, E-cigarettes in Final Tobacco-deeming Rule, Say AAFP, Other Groups

More From AAFP
Tobacco: Preventing and Treating Nicotine Dependence and Tobacco Use (Position Paper)

Policy on Electronic Cigarettes